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| Sponsor: | Roche Global Development |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002330 |
Purpose
To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of hypersensitivity to acyclovir or ganciclovir.
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham / AIDS Outpatient Clinic | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Univ of Arizona / Health Science Ctr | |
| Tucson, Arizona, United States, 85724 | |
| Dr Ken Fisher | |
| Phoenix, Arizona, United States, 85013 | |
| McDowell Clinic | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| AIDS Clinical Research Ctr / UCLA Med Ctr | |
| Los Angeles, California, United States, 900951793 | |
| Mount Zion Med Ctr / UCSF | |
| San Francisco, California, United States, 94115 | |
| UCSD Med Ctr / Pediatrics | |
| San Diego, California, United States, 92103 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Community Research Initiative | |
| Coral Gables, Florida, United States, 33146 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Hawaii | |
| Margo Heath - Chiozzi | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Maryland | |
| Univ of Maryland School of Medicine | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Missouri | |
| AIDS Clinical Trials Unit | |
| St. Louis, Missouri, United States, 63108 | |
| United States, Nevada | |
| HIV Wellness Ctr / Univ Med Ctr | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Mexico | |
| Univ of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| AIDS Wellness Clinic | |
| Sante Fe, New Mexico, United States, 87501 | |
| United States, New York | |
| Dr Dorothy Friedberg | |
| New York, New York, United States, 10016 | |
| New York Hosp - Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Univ of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Nalle Clinic | |
| Charlotte, North Carolina, United States, 282072198 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State Univ Hosp | |
| Columbus, Ohio, United States, 432101228 | |
| United States, Oklahoma | |
| Associates Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| N Texas Ctr for AIDS & Clin Rsch | |
| Dallas, Texas, United States, 75219 | |
| Dr Daniel Barbero | |
| Fort Worth, Texas, United States, 76104 | |
| Audie L Murphy Veterans Administration Hosp | |
| San Antonio, Texas, United States, 78284 | |
| Infectious Diseases Association of Houston | |
| Houston, Texas, United States, 77030 | |
| Texas Tech Health Sciences Ctr | |
| El Paso, Texas, United States, 79905 | |
| Austin Infectious Disease Consultants | |
| Austin, Texas, United States, 78705 | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
More Information
| Study ID Numbers: | 059F, GANs2226 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002330 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Retinitis Infection Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Retinal Diseases RNA Virus Infections Immune System Diseases Eye Infections, Viral Eye Diseases |
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |